Device Classification Name |
oximeter
|
510(k) Number |
K973991 |
Device Name |
METRON QA-510 SPO2 ANALYZER |
Applicant |
METRON U.S., INC. |
P.O. BOX 4343 |
CROFTON,
MD
21114 -4341
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
METRON U.S., INC. |
P.O. BOX 4343 |
CROFTON,
MD
21114 -4341
|
|
Correspondent Contact |
E.J. Smith |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/21/1997 |
Decision Date | 01/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|